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New treatment option for Status Epilepticus
Official title Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
ClinicalTrials.gov ID: NCT06907173
What this study is testing
What is Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET)?
Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for status epilepticus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to determine if treatment of patients with two doses of ketamine plus levetiracetam versus levetiracetam alone leads to more effective control of status epilepticus.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- The patient was witnessed to have a convulsive seizure for greater than 5-minute duration
- The patient received an adequate dose of benzodiazepines. The doses may be divided.
- The last dose of a benzodiazepine was administered 5-30 minutes before study drug administration.
- Continued or recurring seizures in the Emergency Department.
- Age 1 years or older
You likely can't join if
- Known pregnancy
- Prisoner
- Opt-out identification or otherwise known to be previously enrolled in KESETT
- Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital, or other agents defined in the MoP) for this episode of SE
- Treatment with sedatives with anticonvulsant properties other than benzodiazepines for this episode of SE(propofol, etomidate, ketamine or other...
- Endotracheal intubation prior to enrollment
See the full eligibility criteria
- The patient was witnessed to have a convulsive seizure for greater than 5-minute duration
- The patient received an adequate dose of benzodiazepines. The doses may be divided.
- The last dose of a benzodiazepine was administered 5-30 minutes before study drug administration.
- Continued or recurring seizures in the Emergency Department.
- Age 1 years or older
- Known or estimated weight ≥10 Kg
- Known pregnancy
- Prisoner
- Opt-out identification or otherwise known to be previously enrolled in KESETT
- Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital, or other agents defined in the MoP) for this episode of SE
- Treatment with sedatives with anticonvulsant properties other than benzodiazepines for this episode of SE(propofol, etomidate, ketamine or other agents defined in the MoP)
- Endotracheal intubation prior to enrollment
- Acute traumatic brain injury clearly precedes seizures
- Scalp injury or burn preventing EEG placement
- Known allergy or other known contraindication to KET or LEV
- Hypoglycemia \< 50 mg/dL
- Hyperglycemia \> 400 mg/dL
- Cardiac arrest / post-anoxic seizures
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Newark, Delaware, United States
- Wilmington, Delaware, United States
- Washington D.C., District of Columbia, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Syracuse, New York, United States
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Los Angeles, California, United States; Palo Alto, California, United States; Sacramento, California, United States; San Francisco, California, United States; New Haven, Connecticut, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.